UK GDPR for Clinical Trial Sites: What Your Systems Must Do
UK GDPR compliance in trials rests on an Article 6 lawful basis of public task or legitimate interests, the Article 9(2)(j) research condition and the Data Protection Act 2018 safeguards. This guide covers the six legal layers, the controller split, what a platform must do, where trial data may be hosted and what the Data (Use and Access) Act 2025 changes.
Is It Safe to Use AI in GxP Clinical Trial Systems? What MHRA Expects
Yes, where the system is validated for its intended use, a named person reviews each output before it becomes a record, and the audit trail shows what the model proposed and who confirmed it. This guide covers what the MHRA has published, the fabricated-citation failure mode, the may and must-never list, the audit trail, change control and the vendor questions.
What Does an MHRA Inspector Look For in a Pharmacy Site File?
An MHRA inspector looks in a pharmacy site file for evidence that the site can rebuild the history of any unit of investigational medicinal product on demand. This guide covers the notification and dossier, what is requested and in what order, the walkthrough, the single unit trace and how findings are graded.
Who Releases IMP to a UK Site, and What Is QP Release?
A Qualified Person releases an IMP batch by certifying it, and the sponsor releases that stock to a named site. This guide covers QP certification, the MIA(IMP) behind it, how an imported product reaches a UK site, the green light to dispense, and which release documents a pharmacy files.
IMP Labelling Requirements for UK Trials
IMP labelling requirements for UK trials are set by regulation 46 of the Clinical Trials Regulations, as amended from 28 April 2026. This guide covers the particulars a full label must show, which labelling set applies to which product, who may apply or change a label, and expiry extension at site.
Blinding in the Pharmacy: Keeping the Secret and Breaking It in an Emergency
Blinding in the pharmacy means holding the treatment allocation out of reach of the trial team, and releasing it for one participant when a clinical emergency requires it. This guide covers who may know what is inside a kit, what ICH E6(R3) section 2.11 requires, how a code break runs, and what is recorded.
Delegation and Training: Why Who Did It Matters as Much as What Was Done
A pharmacy record entry counts as evidence when the person who made it was delegated that activity and trained for it on the day. This guide covers the authorised-and-trained condition, what a delegation log records, which activities need documenting, training currency, and what an inspector asks.
What Does ICH E6(R3) Require of IMP Management at the Site?
ICH E6(R3) requires the investigator or institution to hold responsibility for IMP management at the site, and section 2.10 sets that duty out in nine clauses. This guide takes each clause as it applies at a UK site, the conditions on delegating to a pharmacist, and where the sponsor’s duty begins.
IMP vs NIMP: Which Products Need Trial-Grade Records?
An investigational medicinal product needs a trial-grade record, and a non-investigational medicinal product needs the record its protocol specifies. This guide covers who fixes each product’s class, the record each class attracts at a UK site, and how a misclassification breaks the pharmacy log.
Why the Hospital Pharmacy Stock System Is Not a Trial Record
A hospital pharmacy stock system is built to control the trust’s inventory, and a trial record has to account for each numbered unit against a participant. This guide covers what a stock system evidences, the per-participant and audit trail gaps, and how a site holds both records without drift.
